Kornimate/medical-research-clean huggingface dataset:
protocol for drug use investigation of follistim injection (study p06132)(completed)

Conditions: Anovulation

Summary: the main purpose of this investigation is to collect information about safety and efficacy of follistim injection from actual clinical use to induce ovulation in patients with anovulation and oligoovulation due to hypothalamus-pituitary dysfunction. post-marketing surveys are not considered applicable clinical trials and thus the results of this survey will not be posted at its conclusion. the results will be submitted to public health officials as required by applicable national and international laws.


Eligibility criteria:
inclusion criteria: * patients who underwent ivf exclusion criteria: * patients with tumors of ovary, breast, uterus, pituitary or hypothalamus * pregnant or possible pregnant women, or lactating women * patients with undiagnosed atypical vaginal bleeding * patients with a history of hypersensitivity to any of the ingredients of this product * patients with ovarian cysts or enlarged ovaries, not related to polycystic ovarian disease
graduated embryo score (ges) in the fresh cycle predicts outcome from frozen embryo transfer

Conditions: Infertility

Summary: evaluation of embryo quality in the fresh cycle as a predictor of outcome from frozen embryo transfer.

outcomes from frozen embryo transfer reviewed based on the quality of the embryos in the ftresh cycle as assessed by the graduatede embryo score.

Eligibility criteria:
inclusion criteria: * 2 frozen blastocysts

Keywords: cryopreservation frozen embryo transfer graduated embryo score
evaluating the efficacy of ai-guided (genais tm) vs. standard physician-guided dietary supplement prescriptions for lowering ldl cholesterol in hypercholesterolemic patients

Conditions: Hypercholesterolemia

Summary: the trial compared ai-guided and standard physician-guided dietary supplement (ds) prescriptions for lowering ldl cholesterol (ldl-c) in hypercholesterolemic patients. the ai system used genetic, metabolic, and clinical data to personalize ds regimens, hypothesizing superior efficacy over traditional methods. this 3-month randomized, controlled trial involved adults aged 40-75 with specific ldl-c levels, excluding those with significant health risks. participants were divided into a control group with physician-guided ds and an ai-guided group. the ai system from triangel scientific provided dynamic, personalized recommendations. baseline and follow-up measurements included lipid profiles and adherence assessments. the ai-guided group showed significantly greater ldl-c reduction and improvement in other lipid markers. the study concluded that ai-guided ds prescriptions are more effective, suggesting a promising future for ai in personalized cholesterol management.


Eligibility criteria:
inclusion criteria: * age between 40 and 75 years. * ldl-c level between 70 and 190 mg/dl, confirmed in at least two sequential checks conducted within the last six months prior to signing the consent form. exclusion criteria: * personal history of cardiovascular disease or high risk (≥ 20%). * triglycerides (tg) ≥ 400 mg/dl. * body mass index (bmi) ≥ 35 kg/m² * use of lipid-lowering drugs or supplements affecting lipid metabolism within the last three months. * diabetes mellitus. * known severe or uncontrolled thyroid, liver, renal, or muscle diseases.

Keywords: ldl cholesterol reduction ai-guided prescriptions dietary supplements personalized nutrition
comparative efficacy of the suppository versus guaiacol suppository versus guaifenesin syrup in pediatric patients with cough due the infectious origin

Conditions: Cough

Summary: it is believed that the suppository consisting of guaiacol, menthol, camphor and eucalyptol, by their pharmacological properties already established for each component, has the ability to reduce the signs and symptoms related to upper respiratory infections in a manner equivalent (not inferior) to medicine used as a comparator in this study and higher than the suppository containing only guaiacol concentration of 12.5 mg.


Eligibility criteria:
inclusion criteria: * patients that parents or legal guardians agree to their participation in the study and agree on the terms proposed in the ic, signing it; * patients aged ≥ (greater than or equal to) 02 years and ≤ (less than or equal to) 6 years, 11 months and 29 days, of any ethnicity, class or social group. * patients with acute respiratory disease of upper respiratory viral diseases (uri); * patients with productive cough; * clinical picture of uri defined by the doctor that started less than 48 hours. exclusion criteria: * patients being treated with antibiotics; * presence of clinical features of bacterial infection of the upper airways and / or pulmonary (acute bacterial sinusitis, pneumonia, etc.). * patients with non-productive cough; * treatment with immunosuppressive drugs; * presence of any medical condition that, according to the investigator, should prevent the patient from the study; * participation in clinical trials in the 12 months preceding the study, according to resolution 251 (anvisa), august 7, 1997, item iii, sub-item j; * patients with serious diseases; * patients who require multidrug treatment; * presence of other concomitant pulmonary diseases * history of hypersensitivity to drugs of the same pharmacological classes of substances under investigation; * patients with diseases that interfere with lung function, such as cerebral palsy or muscular atrophies; * patients under medication or supplement (eg physiotherapy) that may interfere with the cough; * patients with severe dysfunction of the hepatorenal function; * patients with x-ray of the chest or sinus compatible with picture of bacterial infection; * patients with blood cell count suggestive of bacterial infection; * changes in laboratory, clinical, physical and / or radiological agents that, judged by investigators, could compromise patient health or reliability of the data.

Keywords: cough treatment
trauma reception and resuscitation project

Conditions: Trauma

Summary: test the hypothesis that the implementation of real-time, computer-prompted algorithms in the first half hour of trauma management will result in a measurable reduction in management errors associated with the reception and resuscitation of major trauma patients. demonstrate that a reduction in management errors will translate into a reduction in morbidity and mortality.


Eligibility criteria:
inclusion criteria: all injured patients \> 15 years old who are brought or present to the the alfred trauma centre during the study period. exclusion criteria: stable trauma patients (ie pulse rate \ 70mmhg, hb \>70, temperature \>35 and \ 92%, gcs \>13) undergoing secondary transfer from another hospital, where trauma occurred \>6hrs prior to arrival.

Keywords: trauma wounds injuries
basel stent kosten effektivitäts trial drug eluting balloons vs. drug eluting stents in small vessel interventions

Conditions: Coronary Heart Disease

Summary: the investigators hypothesize that in a real-world population undergoing percutaneous coronary intervention (pci) for de-novo stenoses in small native vessels with a diameter \<3 mm, drug eluting balloons (deb) are non inferior to third-generation drug eluting stents (des).

drug-eluting balloons are an established treatment for in-stent stenoses and showed good results in small vessels. moreover, the available data suggest that deb are a promising new technique for the treatment of de-novo stenoses in small vessels if pre-dilatation is performed and geographical mismatch is avoided. the aim of this study is to demonstrate that deb is non-inferior to des in a real-world population with respect to the combined clinical endpoint major adverse cardiac events (mace), defined as cardiac death, non-fatal myocardial infarction, and target vessel revascularization after 12 months.

Eligibility criteria:
inclusion criteria: * angina pectoris canadian cardiovascular society (ccs) 2 to 4 or silent ischemia as assessed by stress echocardiography, stress cardiac magnetic resonance, myocardial perfusion scintigraphy, or fractional flow reserve * pci of de-novo stenosis in vessels ≥2.0 to \<3.0 mm in diameter irrespective of the indication (concomitant pci of a vessel ≥3.0 mm in diameter is permitted if the stenosis is located in a coronary artery other than the culprit vessel) * no flow-limiting dissection (timi ≤2) or residual stenosis \>30% after initial dilatation with a standard or non-compliant balloon, as assessed by the physician in charge * written informed consent exclusion criteria: * concomitant large-diameter pci in the same coronary artery (lad, ramus circumflexus (rcx), rca) * pci of instent-restenosis (culprit lesion) * life expectancy \<12 months * pregnancy * enrolled in another coronary intervention study * unable to give informed consent
sleepiness and sleep-disordered breathing in fabry disease. a prospective cohort study.

Conditions: Fabry Disease

Summary: prospective, observational cohort study to investigate the prevalence of sleepiness and sleep-related breathing disorders in patients with fabry disease (fd). for this, an epworth sleepiness score (ess) and ambulatory overnight respiratory polygraphy (orp) is obtained in all subjects.

there are 76 patients with fabry disease in the region of eastern switzerland who are observed and treated in the university hospital zurich. all patients are encountered in retrospective cohort study, and all patients are asked to participate in the study by obtaining written informed consent. eligible fabry patients are investigated by completion of ess and one ambulatory overnight respiratory polygraphy (orp). an ess over 11 is defined as excessive daytime sleepiness(eds). an apnoea/hypopnoea index (ahi) over 5 per minute is defined as sleep apnoea. distinction of obstructive sleep apnoea (osa) and central sleep apnoea (csa) is performed by analysis of orp. medical history, clinical and laboratory data, and current treatment will be extracted from patient files and the retrospective cohort study, respectively. the patients are asked to participate in the study at clinically regular follow-up visits. after obtaining informed consent, the subjects are provided for reviewing in- and exclusion criteria. for this, additional laboratory analyses and completion of ess and patient's health questionnaire (phq-9) is required. the screening visit is encountered in the routine clinical follow-up examination. after obtaining informed consent, the subjects are provided for reviewing in- and exclusion criteria. for this, the laboratory results (s. exclusion criteria), which are part of the routine follow-up examination, are checked, and phq-9 and ess are completed together with the patient. in case of fulfilling all inclusion criteria without presence of exclusion criteria, the patients are scheduled by telephone call for visit 1 (orp). eligible fabry patients are investigated one ambulatory overnight respiratory polygraphy (orp). for this reason, the subjects are asked to pick-up and learn the self-administration of the orp device (apnealink™ plus (resmed)). the orp itself is easily performed at subject's home. the following day, the patients need to return the device, or, alternatively, they can send it by post. after orp, there is no need for further visits for purpose of the study. the subjects are informed about the results of orp during the next regular clinical follow-up visit. orp is a non-invasive medical examination technique, which is routinely applied to detect sleep-related breathing disorders. for purpose of the orp, the apnealink™ plus (resmed), a home sleep testing diagnostic device that provides simple, cost-effective and reliable results, is applied. the subjects will be instructed in the usage of the device, so that they can install themselves in the study night.

Eligibility criteria:
inclusion criteria: established diagnosis of fabry disease, who * are 18 years or above * have signed informed consent.
effect of mirror therapy versus bilateral arm training for rehabilitation after chronic stroke

Conditions: Stroke

Summary: the study purpose is to compare the efficacy of mirror therapy and bilateral arm training on movement strategies of the affected upper extremity and functional outcome in chronic stroke patients.

study background: approximately 80% of stroke survivors have an upper and/or lower limb impairment (barker 1997), and impairment of the arm explains up to 50% of the variance in functional limitation after stroke. brain imaging research using magnetoencephalography found that mirror therapy combined with bilateral arm training could potentially aid stroke rehabilitation by normalizing an asymmetrical pattern of movement-related beta desynchronization in primary motor cortex. however, different neural mechanisms may cause different effect of motor control recovery after the two different approaches, which have yet to be studied. study purpose：to compare the efficacy of mirror therapy and bilateral arm training on movement strategies of the affected upper extremity and functional outcome in chronic stroke patients. study method: this was a single-blind, randomized, comparative efficacy research. sixty participants with chronic stroke will be recruited in the occupational therapy clinics at four hospitals and randomly assigned to the mirror therapy and bilateral arm training groups. the intervention will consist of 1.5 hrs/day, 5 days/wk for 4 wks, including 3 days of hospital-based therapy and 5 days of home practice. primary outcomes were muscular properties (grip strength) and sensorimotor measurements. secondary outcomes included measures of daily functions to gain insight about movement capabilities. the validity and reliability of all measurements have been proposed. finally, the mann-whitney u test and the fisher exact test will be used to compare the significant differences between the two approaches. the effect size of dependent variables will be reported also.

Eligibility criteria:
inclusion criteria: * more than 6 months after onset of an ischemic or hemorrhage stroke * no excessive spasticity on all joints of the affected arm exclusion criteria: * history of stroke or other neurologic, neuromuscular, or orthopedic disease * participation in other experimental rehabilitation or drug studies concurrent with this study

Keywords: stroke randomized control trial mirror therapy bilateral arm training comparative efficacy research neurorehabilitation
the new pharmaceutical composition containing botulinum toxin to treat atrial fibrillation

Conditions: Atrial Fibrillation; Ischemic Heart Disease

Summary: the aim of this prospective randomized double-blind study was to compare the efficacy of new pharmaceutical composition containing botulinum toxin injection in epicardial fat pads for preventing recurrences of atrial tachyarrhythmia in patients with paroxysmal atrial fibrillation undergoing coronary artery bypass grafting.


Eligibility criteria:
inclusion criteria: * patients with paroxysmal af (recurrent episodes for at least 2 years, with ≥ 6 episodes over the last 6 months) * at least one failed antiarrhythmic drug * indication for cardiac surgery (e.g. coronary artery bypass grafting, valve repair/replacement) according to the american college of cardiology/american heart association (acc/aha) guidelines for cardiac surgery exclusion criteria: previous heart surgery or atrial fibrillation ablation procedure emergency coronary artery bypass grafting unstable angina or heart failure persistent atrial fibrillation or atrial fibrillation at the time of screening planned maze procedure or pulmonary vein isolation unwillingness to participate

Keywords: atrial fibrillation botulinum toxin ischemic heart disease
effect of platelet rich plasma and keratinocyte suspensions on wound healing

Conditions: Skin Graft

Summary: this prospective randomized trial evaluated the impact of autologous keratinocytes suspended in platelet concentrates on healing skin graft donor site wounds. it was hypothesized that the treatment would speed and improve wound healing.


Eligibility criteria:
inclusion criteria: * skin graft donor sites total surface \< 15% bsa * skin graft donor site size: 0.2mm deep, 30 to 40 cm2 surface area exclusion criteria: * patients treated with immunosuppressors * patients treated with corticoids * patients suffering from terminal renal insufficiency * patients suffering from severe peripheral arteriopathy

Keywords: skin graft donor site healing skin wound platelet concentrate keratinocytes burns
asxl-related disorders natural history study

Conditions: Bohring-Opitz Syndrome; ASXL1 Gene Mutation; Shashi-Pena Syndrome; ASXL2 Gene Mutation; Bainbridge-Ropers Syndrome; ASXL3 Gene Mutation

Summary: a registry focused on the natural history, management and treatment of patients with bohring-opitz syndrome (asxl1), shashi-pena syndrome (asxl2) and bainbridge-ropers syndrome (asxl3).

study participants will be asked to complete a series of brief surveys over time about their medical condition. the researchers will also attain primary medical records.the registry is based at ucla as the irb of record with collaborating sites at boston children's hospital, cincinnati children's hospital, and duke university in a partnership with the bohring-opitz syndrome (bos) foundation and asxl-rare research endowment (arre). the bos foundation and arre are non-profit organizations run by families of patients with asxl-related disorders that are focused on supporting research. the data is co-managed by the researchers and the family groups. aggregate data from the registry will be shared with the participants as well as used for publication. the registry is hippa compliant and follows all the irb requirements regarding securing and managing patient data.

Eligibility criteria:
inclusion criteria: * clinical or molecular diagnosis of an asxl related disorder exclusion criteria: * no clinical or molecular diagnosis of an asxl related disorder
efficacy of viome's precision nutrition program towards reducing hba1c

Conditions: Diabetes; Pre Diabetes

Summary: this is a randomized, placebo-controlled trial that will test the efficacy of vpnp in reducing hba1c. participant recruitment will occur through direct-to-participant enrollment. no additional clinical sites will be used for recruitment.

this is a randomized, placebo-controlled trial that will test the efficacy of vpnp in reducing hba1c. participants with hba1c levels between 5.7-8.9% (inclusive) will be recruited and randomized into either the placebo or intervention group. the study duration for each participant will be approximately 90 days. at the beginning of the 90 days, the participant will complete online questionnaires, a blood draw, and a set of at-home sample collections for blood, stool, and saliva that will be sent back to viome. after the samples are analyzed, the participant will receive dietary recommendations (either personalized or usda) and supplements (either personalized or placebo). the participant will follow the dietary recommendations and take the supplements for 90 days. at the end of the 90 days, the participant will once again complete online questionnaires, a blood draw, and a set of at-home sample collections for blood, stool, and saliva that will be sent back to viome for analysis.

Eligibility criteria:
inclusion criteria: * signed and dated informed consent form and medical release prior to any trial-specific procedures are performed * females and males aged 18 years or older * able to speak and read english * hba1c between 5.7-8.9% (inclusive), tested within the past 30 days * willing and able to visit a quest diagnostic patient service center (psc) * willing and able to follow the trial instructions and viome's precision nutrition program * willing and able to use a smartphone and viome app. exclusion criteria: * antibiotic use within one month of the gi test * gestation within previous 6 month * current (or previous) use of medications that increase insulin (sulfonylureas, such as glimepiride, glipizide, glyburide, etc.) * current (or previous) use of exogenous insulin (such as tresiba, lantus, toujeo, levemir, humalog, novolog, apidra, fiasp, etc.) * on a specific diet, such as ketogenic, for the purpose of reducing hba1c and/or weight within the previous month * taking diet pills * allergy to an ingredient in the mh capsule or stick pack * currently on an investigational product * significant surgery or medical procedure planned * diet or lifestyle change during the trial period, besides those appropriate for trial arm has followed viome nutritional recommendations (foods and/or supplements)

Keywords: health wellness nutrition vitamins supplements prebiotics probiotics fitness blood sugar
dose confirmation study of cotara for the treatment of glioblastoma multiforme at first relapse

Conditions: Glioblastoma Multiforme

Summary: cotara® is an experimental new treatment that links a radioactive isotope (iodine 131) to a targeted monoclonal antibody. this monoclonal antibody is designed to bind tumor cells and deliver radiation directly to the center of the tumor mass while minimizing effects on normal tissues. cotara® thus literally destroys the tumor "from the inside out". this may be an effective treatment for glioblastoma multiforme, a malignant type of brain cancer.

to confirm the safety and tolerability of the maximum tolerated dose (mtd) of 131i-chtnt-1/b mab given as a single interstitial infusion in patients with glioblastoma multiforme at first relapse. to estimate overall survival, progression free survival and proportion of patients alive at six months after treatment.

Eligibility criteria:
inclusion criteria: * histologically confirmed gbm * clinical target volume between 5 and 60 cc (inclusive) * 18 to 75 years old (inclusive) * karnofsky performance status ≥ 70 percent * if on steroids dose (± 4mg/day) must be stable for at least two weeks prior to screening/baseline visit. if not on steroids for two weeks prior to screening/baseline visit are allowed * adequate hematology * adequate renal function * adequate liver function exclusion criteria: * infratentorial tumor(s), tumor(s) that communicate with the ventricles or intraventricular disease * bilateral non-contiguous gadolinium enhancing tumor * diffuse disease (i.e., any satellite lesions less than 1.5 cm from anticipated location of any catheter tip or less than two satellite lesions) * known or suspected allergy to study medication or iodine * surgical procedure within four weeks of baseline * more than one prior chemotherapy regime or chemotherapy within four weeks (nitrosourea-based within six weeks) of baseline * radiation therapy within four weeks of baseline * investigational agent within last 30 days * previous treatment with any chimeric monoclonal antibody * hiv positive * evidence of active hepatitis

Keywords: glioblastoma multiforme gbm brain cancer cotara radioactive isotope monoclonal antibody glioblastoma multiforme at first relapse
relationship between mid-luteal serum progesterone levels to pregnancy rates in assisted reproductive techniques (art)

Conditions: Infertility

Summary: in assisted reproductive techniques (art) there is a need for luteal support using progesterone, estrogen and probably human chorionic gonadotropin (hcg). the optimal route of administration and dose has not yet been determined. the aim of the study is to investigate whether high levels of mid-luteal serum progesterone are related to higher pregnancy rates in art cycles. we also plan to investigate whether using higher doses of vaginal progesterone results in higher pregnancy rates.


Eligibility criteria:
inclusion criteria: * mid-luteal serum progesterone levels below 15 ng/dl exclusion criteria: * does not sign consent form